Postmenopausal Osteoporosis

Transcription

1 Osteoporosis Products Available in Canada for the Treatment and Prevention of Postmenopausal Osteoporosis Physician Desk Reference - 2nd Edition A clinical resource provided to you by: The Society of Obstetricians and Gynaecologists of Canada

2 ASSESSING RISK The goals of osteoporosis management includes assessment of fracture risk and prevention of fracture, both vertebral (manifested as height loss) and nonvertebral. A Bone Mineral Density (BMD) test is only one component of assessing a woman s risk for fracture. The fracture risk assessment requires integration of the key multiple risk factors for fracture. ASSESSMENT OF BASAL 10-YEAR FRACTURE RISK WOMEN T-score, Femoral Neck Women Low risk (<10%) Age (year) Moderate risk High risk (>20%) Key risk factors to assess fracture risk in women age 50 years Sex Age BMD Fragility fracture after age 40 Prolonged systemic glucocorticoid use ( 3 mos in the prior year of a prednisone equivalent 7.5 mg daily) in the prior year CAROC Osteoporosis Canada recommends that 10 year absolute fracture risk be determined by integrating key risk factors for fracture by using the 2010 Canadian Association of Radiologists/ Osteoporosis Canada (CAROC) tool or the FRAX tool ( FRAX A World Health Organization collaborating centre has developed the FRAX tool to calculate fracture risk at the hip or for a major fragility fracture (spine, hip, radius or humerus) over the following 10 years ( It is based on the BMD at the femoral neck as well as the following important risk factors for fracture: Age, weight, height, prior fragility fracture, parental history of hip fracture, smoking status, use of prednisone, presence of rheumatoid arthritis, presence of a secondary cause for osteoporosis such as hyperthyroidism, alcohol intake of 3 or more drinks per day. Treatment is recommended if the 10 year fracture risk at the hip is 3% or for a major osteoporotic fracture is 20%. Risk factors are additive, meaning that the more risk factors, the greater the risk of developing osteoporosis. Assessing risk factors can help identify those that are modifiable, which include lifestyle factors. Making lifestyle changes such as smoking cessation can lower fracture risk and can improve bone health. (Osteoporosis Canada, 2011) 2

3 PHYSICAL ACTIVITY, NUTRITION AND SUPPLEMENTS FOR OSTEOPOROSIS MANAGEMENT SOGC Recommendations on Lifestyle Strategies to Manage Osteoporosis Early assessment of skeletal health, initiation of vitamin D supplements as well as a diet enriched in calcium, and a strenuous daily exercise program are essential in the prevention and treatment of osteoporosis. 1 Osteoporosis Canada Recommendations on Lifestyle Interventions For all patients, regular weight-bearing, balance and strengthening exercises, smoking cessation, and optimization of total (dietary and supplements) calcium and vitamin D intake are recommended. For patients at risk of falls, fall-prevention strategies should also be implemented. 2 Regular exercise Calcium and vitamin D Resistance training appropriate for the individual s age and functional capacity and/or weight-bearing aerobic exercises Exercises to enhance core stability Exercises that focus on balance or on balance and gait training Total daily intake of elemental calcium through diet and supplements (if needed): Adults 19 to 50: 1,000 mg Adults 50+: 1,200 mg Vitamin D daily supplementation: Adults 19 to 50: 400 1,000 IU Adults 50+ (or those younger adults at high risk (with osteoporosis, multiple fractures, or conditions affecting vitamin D absorption): 800 2,000 IU, or as required for the patient based on the results of serum 25 hydroxyvitamin D (ideal range is nmol/l) Diet/nutrition Limit coffee intake (<4 cups/day) Limit alcohol intake (<2 drinks/day) Smoking cessation should be strongly advised 3

4 Recommendations for patients on how to take calcium supplements: Encourage patients to meet their calcium requirements from dietary sources, such as 3 4 servings of dairy daily (each glass of milk contains approximately 300 mg elemental calcium). Visit HerNutrition.ca for additional sources of calcium. If calcium requirements are not met from dietary sources, then supplements should be taken. Calcium carbonate is 40% elemental calcium, and is best absorbed in an acidic gastric ph. Individuals taking proton pump inhibitors are advised to take their calcium supplement with food to ensure best absorption. Calcium citrate is approximately 21% elemental calcium and can be taken at any time as it does not require an acidic ph for absorption. It is suitable for those with achlorhydria or those using PPIs. Other calcium supplements, such as calcium gluconate or calcium lactate, are not recommended as they contain a very small amount of elemental calcium. TUMS contain calcium carbonate and are useful calcium supplements. It is best to have patients take smaller doses of calcium more frequently, or a slow release formulation rather than a large dose once a day. 4

5 PRESCRIBING THERAPIES FOR POSTMENOPAUSAL OSTEOPOROSIS For individuals with postmenopausal osteoporosis, there are a variety of drug treatments available. This guide aims to assist physicians with optimizing treatment decisions by summarizing some of the key information about all of the drug treatments currently available in Canada. For complete information about the individual treatments in this guide, please consult the respective product monographs on Health Canada s drug product database. 3 Providers should check the full prescribing information for appropriate dosages for the indication and any updates or information that is not provided here, such as warnings and contraindications. First-line medications for postmenopausal osteoporosis treatment and/or prevention SOGC Recommendations on Treatment of Osteoporosis Pharmacologic therapy is considered in after exclusion of secondary causes of low bone density. If the 10-year absolute fracture risk is greater than 20% (high), then drug therapy is advised. In those with a moderate risk (10% to 20%), management decisions are individualized. 1 Selective Estrogen-Receptor Modulator (SERM) Raloxifene hydrochloride EVISTA Eli Lilly Canada Inc. 60 mg Treatment and prevention of osteoporosis in Estrogen and Selective Estrogen-Receptor Modulator (SERM) FDA Conjugated estrogens +bazedoxifene DUAVIVE Pfizer Canada Inc mg conjugated estrogens + 20 mg bazedoxifene 5

6 Parathyroid hormone Teriparatide (recombinant human parathyroid hormone) FORTEO Eli Lilly Canada Inc. Subcutaneous injection 20 mcg (The maximum lifetime exposure for an individual patient is 24 months) Treatment of with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy Bisphosphonates* Zoledronic acid ACLASTA Novartis Pharmaceuticals Canada Inc. IV 5 mg/100 ml infused for at least 15 minutes Once yearly Treatment of osteoporosis in Risedronate sodium ACTONEL Warner Chilcott Canada Co. (Allergan) 5 mg 35 mg 150 mg (5 mg) (35 mg) Once monthly (150 mg) Treatment and prevention of osteoporosis in Risedronate sodium (delayed release) ACTONEL DR Warner Chilcott Canada Co. (Allergan) 35 mg Treatment of osteoporosis in Alendronate sodium FOSAMAX Merck Canada Inc. 10 mg 70 mg (10 mg) (70 mg) Treatment and prevention of osteoporosis in Alendronate sodium + cholecalciferol (vitamin D3) FOSAVANCE Merck Canada Inc. 70 mg alendronate + 70 mcg cholecalciferol (2,800 IU vitamin D3) 70 mg alendronate mcg cholecalciferol (5,600 IU vitamin D3) Treatment of osteoporosis in Prescribing tip: Because calcium interferes with the absorption of bisphosphonates, calcium supplements must be taken at other times of the day. 6

7 RANK ligand inhibitor** Denosumab PROLIA Amgen Canada Inc. Subcutaneous injection 60 mg/ml in a single use prefilled syringe Once every 6 months Treatment of with osteoporosis at high risk for fracture First-line hormone therapy products for postmenopausal osteoporosis treatment and/or prevention Hormonal therapy Oral 17ß-estradiol (micronized) ESTRACE Acerus Pharmaceuticals Corporation 0.5 mg 1 mg 2 mg Conjugated estrogens PREMARIN Pfizer Canada Inc. 0.3 mg mg 1.25 mg Hormonal therapy Transdermal 17ß-estradiol CLIMARA Bayer Inc. Patch 0.05 mg mg 0.1 mg 17ß-estradiol ESTRADOT Novartis Pharmaceuticals Canada Inc. Patch mg mg 0.05 mg mg 0.1 mg Twice weekly 7

8 *Bisphosphonate Drug Holidays: Bisphosphonates have long term skeletal retention. Long term use beyond 5 years has uncommonly been associated with potential harmful effects including atypical femoral fractures. The bisphosphonate can be interrupted after 3 5 years of use if the fracture risk is moderate and there is no history of a prior fragility fracture and the femoral neck T-score is >-2.5. If the fracture risk is high, ongoing drug therapy is necessary, and consideration can be given to switching to another proven agent, such as teriparatide or denosumab. 4 If the fracture risk is low, drug therapy is not required beyond adequate calcium and vitamin D supplementation. 1 **Atypical Femoral Fractures (AFF): These fractures occur in the femoral shaft and can develop with minimal or no trauma. They can be seen with long term bisphosphonate or denosumab use, or may rarely occur without the use of an antiresorptive agent. 5 AFF are usually preceded by thigh or groin pain. If such symptoms are present, full bilateral femur x-rays are advised to exclude the presence of an incomplete AFF. If features of an early AFF are present, the antiresorptive therapy should be discontinued and consideration should be given to using teriparatide. 5 **Osteonecrosis of the Jaw (ONJ): This is a rare complication of antiresorptive therapy with an incidence of 0.01% 0.001%. Risk factors for ONJ include chemotherapy, major oral surgery or dental trauma, periodontal disease, diabetes, glucocorticoid therapy, long term bisphosphonate or denosumab therapy, as well as antiangiogenic therapy. 6 Patients with ONJ require close monitoring and treatment by a dentist and oral surgeon. 6 The antiresorptive therapy should be discontinued if ONJ develops until the surgical site has fully healed. 6 8

9 References: 1. Khan A, Fortier M, et al. Osteoporosis in Menopause. J Obstet Gynaecol Can 2014; 36(9 esuppl C): S1-S Papaioannou A, et al Clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ 2010; 182(17): Health Canada Product Monographs. Available at: 4. Bisphosphonates for treatment of osteoporosis: expected benefits, potential harms, and drug holidays. Jacques P. Brown, Suzanne Morin, William Leslie, Alexandra Papaioannou, Angela M. Cheung, Kenneth S. Davison, David Goltzman, David Arthur Hanley, Anthony Hodsman, Robert Josse, Algis Jovaisas, Angela Juby, Stephanie Kaiser, Andrew Karaplis, David Kendler, Aliya Khan, Daniel Ngui, Wojciech Olszynski, Louis-Georges Ste-Marie, Jonathan Adachi, Canadian Family Physician April 2014, 60 (4) Atypical Femoral Fracture 5 Things to Know by Aliya Khan and Stephanie Kaiser CMAJ Diagnosis and Management of Osteonecrosis of the Jaw: A Systematic Review and International Consensus. Aliya A Khan, Archie Morrison, David A Hanley, Dieter Felsenberg, Laurie K McCauley, Felice O Ryan, Ian R Reid, Salvatore L Ruggiero, Akira Taguchi, Sotirios Tetradis, Nelson B Watts, Maria Luisa Brandi, Edmund Peters, Teresa Guise, Richard Eastell, Angela M Cheung, Suzanne N Morin, Basel Masri, Cyrus Cooper, Sarah L Morgan, Barbara Obermayer- Pietsch, Bente L Langdahl, Rana Al Dabagh, K. Shawn Davison, David L Kendler, George K Sándor, Robert G Josse, Mohit Bhandari, Mohamed El Rabbany, Dominique D Pierroz, Riad Sulimani, Deborah P Saunders, Jacques P Brown, and Juliet Compston, on behalf of the International Task Force on Osteonecrosis of the Jaw, JBMR 2015 SOGC, January The information contained herein is not intended to substitute for the advice of a physician, and you are advised always to consult your doctor for specific information on personal health matters. Unless otherwise specifically indicated, the naming of any organization, product or therapy, does not imply SOGC endorsement. Reproduction of this document in whole, or in part, is strictly prohibited. 9